Some advocates argue that real-world reports — stories from patients and clinicians, observational data — should be enough to get psychedelic therapies approved. The FDA disagrees: it requires carefully controlled studies where you compare a treatment group to a placebo group under strict conditions. No psychedelic therapy will clear that bar using only real-world evidence by June 2027. This matters because it means approval takes longer and costs much more.
Mechanistic neuroscience continues outpacing validated controlled clinical translation; RWE and case series do not meet the controlled-evidence bar for approval. Falsifiable: an FDA approval citing RWE/case series as primary evidence within the window would refute it.